Propranolol Hydrochloride

ANDA 70309, held by Duramed Pharms Barr. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 70309 (Propranolol Hydrochloride), held by Duramed Pharms Barr, was first approved by FDA on Oct 1, 1986, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 1, 1986
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 1, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride60MG · tablet;oral	Propranolol Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 9, 1989	Supplement 7Labeling	Approved	None posted
Oct 1, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70309
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters